NCT07004309

Brief Summary

This randomized controlled trial aimed to compare the effectiveness of microfluidic sperm sorting and density gradient centrifugation (DGC) in reducing sperm DNA fragmentation index (DFI) and improving clinical outcomes in IVF. A total of 119 couples underwent IVF and were assigned to either microfluidic or DGC sperm preparation. The study evaluated sperm quality, fertilization, embryo development, and live birth rates.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 14, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 4, 2025

Completed
Last Updated

June 5, 2025

Status Verified

June 1, 2025

Enrollment Period

1 year

First QC Date

May 27, 2025

Last Update Submit

June 3, 2025

Conditions

Male InfertilitySperm DNA FragmentationIn Vitro Fertilization (IVF)

Keywords

MicrofluidicsSperm DNA FragmentationIn Vitro FertilizationSperm PreparationICSI

Outcome Measures

Primary Outcomes (2)

  • Sperm DNA Fragmentation Index (DFI)

    DFI measured before and after sperm preparation using SCSA method. Comparison between microfluidics and DGC groups

    Day of oocyte retrieval

  • Live birth rate

    Defined as the delivery of a live-born infant after 22 weeks of gestation. Comparison between microfluidics and DGC groups.

    Up to 9 months after embryo transfer

Secondary Outcomes (7)

  • Sperm motility after preparation

    Immediately after sperm preparation

  • Normal sperm morphology

    Immediately after sperm preparation

  • Fertilization rate

    17-20 hours after ICSI

  • Good-quality embryo rate on Day 2

    Day 2 after fertilization

  • Biochemical pregnancy rate

    10-12 days after embryo transfer

  • +2 more secondary outcomes

Study Arms (2)

Microfluidics Group

EXPERIMENTAL

Semen samples are processed using a microfluidic sperm sorting device (ZyMot). Selected sperm are used for ICSI.

Procedure: Microfluidic sperm sorting

DGC Group

ACTIVE COMPARATOR

Sperm preparation using a discontinuous density gradient method with SpermGrad and SpermRinse media.

Procedure: Density Gradient Centrifugation

Interventions

Microfluidic sperm sortingPROCEDURE

Sperm selection using the ZyMot Microfluidic Sperm Separation Device. Process involves loading semen into microfluidic channels to isolate motile sperm with low DNA fragmentation.

Microfluidics Group
Density Gradient CentrifugationPROCEDURE

Sperm preparation using a discontinuous density gradient technique with SpermGrad and SpermRinse media. Centrifugation separates motile sperm for use in ICSI.

DGC Group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female partner aged between 18 and 40 years
  • Couples undergoing in vitro fertilization (IVF) cycles at the IVF and Tissue Engineering Center, Hanoi Medical University, between January 2022 and January 2024
  • Use of autologous oocytes
  • Use of ejaculated sperm
  • Both partners provide written informed consent

You may not qualify if:

  • Use of donor oocytes or donor sperm
  • Requirement for testicular sperm extraction
  • Diagnosis of oligoasthenozoospermia (OA) based on WHO 2021 criteria
  • Female partner classified as having poor ovarian prognosis according to the POSEIDON 2016 criteria, including:
  • Anti-Müllerian hormone (AMH) level \< 1.2 ng/mL
  • Antral follicle count (AFC) \< 5
  • Or history of poor ovarian response (≤9 oocytes retrieved in previous cycles)
  • Preimplantation genetic testing (PGT) cycles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center of IVF and Tissue Engineering, Hanoi Medical University Hospital

Hà Nội, 100000, Vietnam

Location

MeSH Terms

Conditions

Infertility, Male

Interventions

Centrifugation, Density Gradient

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

UltracentrifugationCentrifugationInvestigative TechniquesChemistry Techniques, Analytical

Study Officials

  • Do Thuy Huong, PhD candidate

    Hanoi Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Embryologists performing ICSI and embryo evaluation were blinded to the group assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomized into two parallel arms: microfluidic sperm sorting vs. density gradient centrifugation, with equal allocation.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD candidate

Study Record Dates

First Submitted

May 27, 2025

First Posted

June 4, 2025

Study Start

March 14, 2023

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

June 5, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared due to the sensitive nature of infertility treatment and to protect patient privacy in compliance with institutional ethics guidelines.

Locations

VN(1)